ICU Medical, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0805-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.

Product Classification:

Class I

Date Initiated: January 3, 2019

Date Posted: March 6, 2019

Recall Number: Z-0805-2019

Event ID: 81942

Reason for Recall:

There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate

Status: Terminated

Product Quantity: 2050 units

Code Information:

Lot Number 3757712

Distribution Pattern:

US Distribution to states of: OH, FL, IA, CA, PA, IL, VA; and internationally to: AUSTRIA, CHINA (TAIWAN), IRELAND, ITALY and SINGAPORE.

Voluntary or Mandated:

Voluntary: Firm initiated